ConvaTec Inset User manual

DISCONNECTING
RECONNECTING
Unomedical a/s - AConvaTec Company .Aaholmvej 1-3 .Osted .4320 Lejre .Denmark .www.infusion-set.com .Made in Mexico
11 Hughes
Irvine, CA 92618, USA
www.betabionics.com
Infusion Set
Instructions for use
10
INS-980-1 2021-03
Click
Click

en Open here
ENG L ISH ( e n )
en Date of Manufacture YYYY-MM-DD en Manufacturer en Use-by (Expiry date) YYYY-MM-DD en LOT number
en Sterilized using ethylene oxide en Reference / model number en
Global Trade Item Number en Do not use if package is damaged
en Keep away from sunlight en Keep Dry en Consult instructions for use en Caution: see instructions for use
en Prescription required, does not
apply in all geographies
en Non-pyrogenic en Do not re-use
MD
en Medical Device
en Single sterile barrier system en Distributed by
2
78 9
Click Click
DISCONNECTING
AinsetTM allows you to temporarily disconnect
your pump without having to change the
infusion set. Hold the adhesive tape in place
by placing a finger just in front of the cannula
housing, and gently squeeze thesides of the
connector. Pull the connector needle straight
out from the cannula housing.
BInsert the disconnect cover into the cannula
housing until you hear a “click”.
RECONNECTING
CIf necessary, prime the infusion set until
medication dispenses from the needle.
CAUTION: When priming the infusion set,
holdthe infusion set with the needle pointing
down.
DPlace a finger on the adhesive tape just in
front of the cannula housing.
EPush the connector needle straight in until
you hear a “click”.
11 Carefully remove theneedle guard by gently
twisting and then pulling it. Check that the
soft cannula does not exceedthe introducer
needle.
CAUTION: Before positioning insetTM over a
clean insertion site, place the tubing in the
slot to ensure that the tubing is not caught
underneath the infusion set during insertion.
12 Insert insetTM: Position insetTM over the
insertion site. Simultaneously press the
round indentations on either side of the
serter to insert the infusion set.
13 Push gently on the center of theserter to
secure the adhesive on the skin.
14 Remove theserter/introducer needle by
grasping the center and pulling it gently
back. Gently massage the adhesive tape
onto the skin. Fillthe empty space in the
cannula with the following amount of insulin:
U-100 insulin:
6 mm : 0.1 units (0.001 ml)
9 mm : 0.2 units (0.002 ml)
15 Push the lid back in place until you hear a
“click.”
the infusion set is not loosened / removed by
accident.
7 Unwinding the tubing: ehttsiwtylluferaC
beginning of the tubing out of theslot. Now
unwind thetubing from theserter by pulling it
carefully upwards.
CAUTION: Do not touch the introducer
needle when unwinding thetubing. Be
careful not to pull too hard when thetubing is
fully released. You could accidentally
remove the infusion set from theserter.
8Connect the infusion set to a pump reservoir
and the pump. Prime infusion set. Ensure
there are no air bubbles in the tubing. Consult
pump manufacturer’s instructions for use.
CAUTION: When priming theinfusion set,
holdthe infusion set with the needle
pointing down to ensure that medication
does not come in contact with the adhesive
backing paper.
9Pull up gently to remove the adhesive
backing paper.
10 Prepare the serter: Place fingers on lined
indentations. Press lined indentations on
each side. Pull spring until you hear a “click”.

3
en See page 4

4
ENGLISH (en)
Indications for use:
The insetTM infusion set is indicated for the
subcutaneous infusion of insulin administered
by an external pump. The infusion set is
indicated for single use.
INTENDED USE
The infusion set is indicated for subcutaneous
infusion of insulin in the treatment of diabetes.
The infusion set has been tested to be
compatible with insulins approved for
subcutaneous infusion.
DESCRIPTION
insetTM is a medical device which combines an
infusion set with an aid for infusion (serter). As
the infusion set is an integrated part of the
serter, insetTM is delivered assembled and
ready for use as a single, sterile unit.
CONTRAINDICATIONS
insetTM is neither intended nor indicated for use
in intravenous infusion of blood or blood
products.
WARNINGS
■ Carefully examine the instructions for use
before inserting insetTM. Failure to follow
instructions may result in pain or injury.
■ inset™ is only sterile and non-pyrogenic
if the packaging is undamaged and
unopened. Do not use if inset™ is already
open or has been damaged. Ensure sterility
by checking if the sterile paper and tamper-
proof seal are undamaged.
■ When using insetTM for the first time, do so
in the presence of a healthcare provider.
Since different individuals have varying
amounts of subcutaneous layer, ensure that
an appropriate cannula length is chosen to
fit your needs.
■ Inaccurate medication delivery, site
irritation or infection may result from
improper insertion or maintenance of your
infusion site.
■ Do not re-insert the introducer needle into
the infusion set. This could cause a tearing
or damage of the soft cannula and may lead
to unpredictable medication flow.
■ Reuse of the infusion set may cause site
irritation or infection and may lead to
inaccurate medication delivery.
■Be sure that the needle guard is removed
before insertion is made.
■If the soft cannula bends during insertion,
apply a new inset™ immediately at a new
site.
PRECAUTIONS
■Never try to fill or free a clogged tubing while
the infusion set is inserted. This may result
in unpredictable medication flow.
■When unwinding, release the tubing with
caution as a hard pull of the tubing can result in
damage to the serter. Ensure that the infusion
set is properly in place in the serter when the
tubing is fully released – see picture 8.
■Do not leave air in the infusion set. Make sure
to fill the tubing completely. Consult pump
manufacturer’s instructions for use.
■inset™ is a single use device and should be
disposed of immediately after use. Do not
clean or re-sterilize.
■Do not in any way put disinfectants, perfumes,
deodorants, cosmetics or other products

5
ENGLISH (en)
containing alcohol or disinfectants in contact
with the connector or the tubing. These may
impact the integrity of the infusion set.
■Replace the infusion set if the adhesive tape
becomes loose or is displaced from its original
site. Since the cannula is soft, it will not cause
any pain if it becomes dislodged, and this may
take place without notice. The soft cannula
must always be completely inserted to receive
the full amount of medication.
■Replace the infusion set every two to three
days, or per your healthcare provider’s
instructions.
■If your insertion site becomes irritated or
infected, replace infusion set and use new site
until the first site has healed.
■Wash your hands before disconnecting and
reconnecting the infusion set. Consult your
healthcare provider on how to compensate for
missed medication when disconnected.
■Never point a loaded serter towards any body
part, where insertion is not desired.
RECOMMENDATIONS
■Check your blood glucose level one to three
hours after insertion of the infusion set.
Measure your blood glucose on a regular
basis. Discuss this with your healthcare
provider.
■Do not change your infusion set just prior
to bedtime, unless blood glucose can be
checked one to three hours after insertion.
■If your blood glucose level becomes
unexplainably high or an occlusion alarm
occurs, check for clogs and leaks. If in doubt,
change your infusion set since the soft cannula
could be dislodged or partially clogged.
Discuss plan to bring down your blood glucose
level with your healthcare provider should
any of these problems arise. Test your blood
glucose level to ensure problem is corrected.
■Carefully monitor your blood glucose levels
when disconnected and after reconnecting.
■If, during the use of this device or as a result
of its use a serious incident has occurred,
please report it to the manufacturer and to your
national authority.
STORAGE & DISPOSAL
■Store inset™ in a cool, dry location at room
temperature. Do not store inset™ in direct
sunlight, or in high humidity.
■Store and handle insulin according to the
manufacturer’s instructions.
■Put the lid back on the serter and dispose in
a proper sharps container according to local
laws, to avoid the risk of needle stick.
■Dispose the used infusion set according to
local regulations for biohazardous waste.

6
ENGLISH (en)
inset™- Preparation and insertion
Read all instructions carefully before using the inset™. For information about pump therapy, possible
errors, and potential risks and their causes, consult your pump manufacturer’s instructions for use before
connecting the infusion set. When using inset™‚ follow proper hygiene procedures. Please see the
corresponding illustrations on page 8-10.
[A] Lid
[B] Needle guard
[C] Soft cannula
[D] Adhesive tape
[E] Cannula housing
[F] Connector needle
[G] Tubing
[H] Introducer needle
[I] Serter
[J] Sterile paper
IMPORTANT NOTE!
[K] Three raised dots – press here when
lifting the lid off (see Figure 6)
[L] Lined indentations – press here when
loading insetTM (see Figure 10)
[M] Round Indentations – press here
simultaneously when releasing insetTM
(see Figure 12)
[N] Disconnect cover (see Figure B)
CONTENTS
1Wash your hands before inserting the
infusion set.
2Suggested insertion sites. Choose an
insertion site as recommended by your
healthcare provider. Do not use an area
right next to your previous infusion site.
3Clean the area for insertion with a
disinfectant as directed by your
healthcare provider. Be sure the area is
air dry before inserting the infusion set.
4 Pull the red tape to remove the seal.
5Remove the sterile paper.
6Press the three raised dots on each
side of the lid firmly with one hand and
lift up the lid with the other hand.
CAUTION: Be careful not to bend or
touch the introducer needle when
preparing the serter and infusion set.
IMPORTANT NOTE! If the infusion set
is not securely placed in the serter with
the needle pointing straight ahead prior
to insertion, pain or minor injury may
occur. To avoid this, please ensure that
the following steps are taken gently so

en Open here
ENG L ISH ( e n )
en Date of Manufacture YYYY-MM-DD en Manufacturer en Use-by (Expiry date) YYYY-MM-DD en LOT number
en Sterilized using ethylene oxide en Reference / model number en Global Trade Item Number en Do not use if package is damaged
en Keep away from sunlight en Keep Dry en Consult instructions for use en Caution: see instructions for use
en Prescription required, does not
apply in all geographies
en Non-pyrogenic en Do not re-use
MD
en Medical Device
en Single sterile barrier system en Distributed by
2
7
8 9
Click Click
DISCONNECTING
AinsetTM allows you to temporarily disconnect
your pump without having to change the
infusion set. Hold the adhesive tape in place
by placing a finger just in front of the cannula
housing, and gently squeeze the sides of the
connector. Pull the connector needle straight
out from the cannula housing.
BInsert the disconnect cover into the cannula
housing until you hear a “click”.
RECONNECTING
CIf necessary, prime the infusion set until
medication dispenses from the needle.
CAUTION: When priming the infusion set,
hold the infusion set with the needle pointing
down.
DPlace a finger on the adhesive tape just in
front of the cannula housing.
EPush the connector needle straight in until
you hear a “click”.
11 Carefully remove the needle guard by gently
twisting and then pulling it. Check that the
soft cannula does not exceed the introducer
needle.
CAUTION: Before positioning insetTM over a
clean insertion site, place the tubing in the
slot to ensure that the tubing is not caught
underneath the infusion set during insertion.
12 Insert insetTM: Position insetTM over the
insertion site. Simultaneously press the
round indentations on either side of the
serter to insert the infusion set.
13 Push gently on the center of the serter to
secure the adhesive on the skin.
14 Remove the serter/introducer needle by
grasping the center and pulling it gently
back. Gently massage the adhesive tape
onto the skin. Fill the empty space in the
cannula with the following amount of insulin:
U-100 insulin:
6 mm : 0.1 units (0.001 ml)
9 mm : 0.2 units (0.002 ml)
15 Push the lid back in place until you hear a
“click.”
the infusion set is not loosened / removed by
accident.
7Unwinding the tubing: ehttsiwtylluferaC
beginning of the tubing out of the slot. Now
unwind the tubing from the serter by pulling it
carefully upwards.
CAUTION: Do not touch the introducer
needle when unwinding the tubing. Be
careful not to pull too hard when the tubing is
fully released. You could accidentally
remove the infusion set from the serter.
8Connect the infusion set to a pump reservoir
and the pump. Prime infusion set. Ensure
there are no air bubbles in the tubing. Consult
pump manufacturer’s instructions for use.
CAUTION: When priming the infusion set,
hold the infusion set with the needle
pointing down to ensure that medication
does not come in contact with the adhesive
backing paper.
9Pull up gently to remove the adhesive
backing paper.
10 Prepare the serter: Place fingers on lined
indentations. Press lined indentations on
each side. Pull spring until you hear a “click”.

8 9
Click Click

DISCONNECTING
RECONNECTING
Unomedical a/s - AConvaTec Company .Aaholmvej 1-3 .Osted .4320 Lejre .Denmark .www.infusion-set.com .Made in Mexico
11 Hughes
Irvine, CA 92618, USA
www.betabionics.com
Infusion Set
Instructions foruse
10
INS-980-1 2021-03
Click
Click

DISCONNECTING
RECONNECTING
Unomedical a/s - AConvaTec Company .Aaholmvej 1-3 .Osted .4320 Lejre .Denmark .www.infusion-set.com .Made in Mexico
11 Hughes
Irvine, CA 92618, USA
www.betabionics.com
Infusion Set
Instructions foruse
10
INS-980-1 2021-03
Click
Click

DISCONNECTING
RECONNECTING
Unomedical a/s - AConvaTec Company .Aaholmvej 1-3 .Osted .4320 Lejre .Denmark .www.infusion-set.com .Made in Mexico
11 Hughes
Irvine, CA 92618, USA
www.betabionics.com
Infusion Set
Instructions foruse
10
INS-980-1 2021-03
Click
Click